Philadelphia, PA – Quality by Design

$999.00–$3,999.00

The practical application of QbD within the pharmaceutical space is a classic application of Design for Six Sigma principles and tools. The overall framework and tools used within QbD, e.g., risk-based quality management, statistical design of experiments (DoE), robust process design, and real-time process control through process analytical technology (PAT) as applied for pharmaceutical QbD efforts are areas of significant expertise for our instructors. The instructors will provide insight, instruction and application guidance for the QbD process and the tools required for its successful execution. Furthermore, they will also provide relevant insights and experiences they have gained through years of real-world QbD situations, as well as providing helpful context regard the current QbD landscape as it relates to current industry practices and regulatory agency interactions.

Product Description

Agenda

NOTE: One-day course participants will obtain a conceptual understanding, while five-day course participants will obtain more detailed and advanced understanding through a combination of hands-on exercises and analysis of various case studies.

One-Day “QbD Overview” Course:

Background and drivers for Pharma QbD

QbD guidance review (ICH Q8/Q9/Q10/Q11)

QbD development process and flow/logic

Introduction and overview of QbD tools

Risk management

Design of Experiments

Design Space

Control Strategies

Current industry and regulatory landscape, and application challenges for QbD

Five-Day Course: One-Day “QbD Overview” PLUS:

Focused hands-on DoE training and practice

Full vs fractional factorials

Optimization and response surfaces

Transfer functions

Detailed training on QbD concepts & tools, e.g.

QTPP and CQAs/CMAs/CPPs

Risk management tools and practices

Design space: development, verification and scale-up

Control strategies, process robustness and proactive management of process variation